In-Life Pharmacokinetic Studies

Pipeline Biotech has been offering in vivo pharmacokinetic studies in the major laboratory animal species since the late 1990s. The laboratory works in a rigorous GLP/GMP environment while understanding the need for progress and rapid study turnover in the early drug discovery process. Clients include many pharma and biotech companies who choose Pipeline Biotech as a preferred in-life partner on grounds of reliability, flexibility and timeliness.

Pharmacokinetic Products

Each new molecule or new formulation of pharmacological interest needs to be investigated for its pharmacokinetic properties, in order to find their best utilization. This is a scientific discipline in its own right that determines the appropriate dose, mode and site of action, the best route of administration as well as the best formulation of drug and vehicle to provide an acceptable therapeutic dose range.

PK-Studies

Pipeline Biotech’s pharmacokinetic studies provide unequivocal evidence of drug exposure and can be conducted in mice, rats, guinea pigs, beagles and miniature pigs. Study types include:

• Bioavailability
• Metabolite profiling
• Biliary excretion
• Mass balance
• Tissue distribution
• Bioequivalence
• Blood-Brain barrier permeability
• Specialized models

These studies can be conducted to GLP or Non-GLP quality standards and within a wide range of dosing regimes including single, repeated, cassette and continuous infusion (IV or SC Alzet Osmotic pumps).

Catheterizations can be made to carotid artery; femoral, jugular or portal veins, and bile duct.

Routes of Administration include peroral, intravenous, intravenous infusion, intraperitoneal, intramuscular, subcutaneous, nebulized inhalation, intranasal, intratracheal, topical, intradermal, intra-auricular, intracardial, intracolonic, and stereotactic intracranial.

Pre-formulation of dose solutions are performed according to sponsor’s advice. Where formulation information is not available, Pipeline Biotech has dedicated lab space for formulation activities and can investigate solubility and best choice of vehicle.

Isotopes

Pipeline Biotech can trace test compounds using radioactive isotopes to detect peptides and protein-based drugs. The laboratory offers standard pharmacokinetic studies using the radioactive isotopes ³H, ¹⁴C, ³²P, ³⁵S and ¹²⁵I.

Clinical Observations

In all pharmacokinetic studies, Pipeline Biotech records visible signs of ill health and any behavioural changes, with any deviation from normal reported with respect to time of onset, duration and intensity. Pipeline Biotech is committed to ensure that all laboratory animals receive humane care and treatment and performs all experiments in accordance with EU regulations and with approval from Denmark’s National Animal Experiments Inspectorate.

PK-Screening as a process

In order to fulfil the needs for rapid PK data we work with PK screening as a process, and have developed standardized assay protocols that will deliver the data fast and in a cost effective manner. The Pipeline Biotech system of standardized assays and protocols is very similar to GMP assay processes and results in rapid throughput with fixed weekly deadlines.

Standardized screening processes improve reproducibility, traceability and secure timely sample delivery every time.

Shipment

Pipeline Biotech ships samples within 24 hours to all major cities in Europe, using a dedicated carrier.

Outsourced studies

Pipeline Biotech understands that clients from different business segments need different services. Not all assignments are exactly the same – nor can they be executed the same way. Therefore, the laboratory offers varying levels of contract services depending on the needs of the specific sponsor and the contractual commitments:

• Standard studies
• Experimental set-ups
• R&D line extension services
• Assay or Screening programmes

Resources

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Supplier Information
Supplier: Pipeline Biotech A/S
Address: Roevedvej 1, 8380 Trige, Denmark
Tel: + 45 8748 9770
Fax: + 45 8748 9771
Website: www.pipeline-biotech.dk